Bioequivalence and Bioavailability Forum

Hi Helmut, thank you for your answer,
If you remember I'm doing my post graduate disertation in pharmacology and the subject is bioequivalence I have already requested your help to understand the results of our omeprazole's bioequivalence study, so I studied statistic of bioequivalence from "Design and Analysis of Bioavailability and Bioequivalence Studies, of Shein-Chung Chow, in chapman edition", and I redid all the calculation:
CVw= 18- 23 % for AUCs and Cmax, GMR= 1,16- 1,17 for AUC and Cmax, treatment effect: it's justified because 100% is 'nt include in CI for all parameters
no sequence and no period effect
subject effect: justified: subjects are'nt multiple homozygote
CI C max : (102,15% 135,62%)
AUC 0-12 : (103,43% 131,02%)
AUC 0-∞: (104,08% 131,25%)

GMR is very high, in bibliography it's the case but in fed condition, so I suspect subjects that's did't respect the 10h fasting condition before study (volunteers are very big problem in our country), and I read that omeprazole is HDVP specially in fed condition (gastro resistant preparation), EMA and FDA recommends fed study for this preparation.
So to find a solution to our study, I want to do a replicate pilote study in fed condition to evaluate real intra subject variability of omeprazole gastro resistant preparation (reference), and in fed condition to control the subjects
what do you think?